PRIVATE PATENTS AND PUBLIC HEALTH

Selection criteria include efficacy, quality, safety, and cost-effectiveness,
and the list is regularly updated to be able to respond to new needs, drug
resistance, medical advances, scientific developments, and new evidence
with regard to efficacy and safety. Affordability is also considered in order
to optimise limited health budgets and prevent the purchase of nonessential
expensive medicines to the detriment of treating other diseases,
though the way in which affordability is treated is changing as more
medically necessary drugs carry increasingly higher prices.
The HIV crisis raised the first major challenge to the affordability
criteria. The 1999 revision of the EDL excluded most antiretroviral
medicines (ARVs) to treat HIV as too expensive for health systems to bear. 212
At the time, the predominant treatment regimen for HIV cost upwards of
US$ 10,000 per person per year. But by 1999, HIV had killed nearly 20
million people and was continuing to kill 8,000 people a day. There were 13
million children orphaned due to AIDS, and almost 35 million people
were living with a virus that could be treated – but mostly was not. 213 To
deem ARVs non-essential had become absurd and risked making the EDL
irrelevant.
In 2001, the WHO began a consultation process to examine the way that
new medicines were included in the WHO Model List of Essential Drugs 214 .
The consultation tackled several cost issues, such as whether high costs
should prevent a medicine from being added to the list, even if it was safe,
effective, and needed to treat a priority health problem like HIV; and
whether global comparisons on cost-effectiveness could be meaningful,
given wide variation in medicines costs around the world. 215
In a series of new procedures 216 arising from this consultation process,
the WHO decided the cost of a medicine could not be the reason to exclude
it if it met other criteria, and that cost-effectiveness comparisons should be
made within a therapeutic area (for example, “identifying the most costeffective
medicine treatment to prevent mother-to-child transmission of
HIV”). These new procedures also changed the term “essential drugs” to
“essential medicines” and established a more systematic, transparent,
participatory and evidence-based approach to selecting medicines for
inclusion, as well as improving linkages between the list and WHO
treatment guidelines and technical departments. The 2002 EML included
a number of ARVs.
The message was clear: cost alone was no longer a criterion for which
an essential medicine could be excluded from the list. The implication
was that steps should be taken to make listed drugs affordable.
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THE NEW FRONTIERS: PATENTS AND TREATMENT FOR CANCER, HEPATITIS C, AND OTHER DISEASES
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